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U.S. Department of Health and Human Services

Product Classification

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Device non-irrigation endosseous dental implant drill bits
Definition The device is intended to prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation.
Physical State The device is composed of metal drill bits.
Technical Method The device incorporates a design/geometry which allows for dental implant site preparation at low speed without irrigation, specific to the surgical protocol of a dental implant system.
Target Area The device is intended for use in the oral cavity for drilling the bone of the upper and lower jaw.
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeQRQ
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(K) Exempt
Regulation Number 872.3980
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
    Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892.
If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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